MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)

NCT01617720 | Completed DMC

• 1 other identifier: VC1-2
• Study Type: observational
• Target: 45
• Locations: 2 countries
• Sites: 2

Brief Summary

This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.

Conditions

Mitral Regurgitation

Keywords

mitral; valve; annuloplasty; mitral regurgitation

Outcome Measures

Primary Outcomes (4)

• • Ability of the Cardinal ring to reduce mitral valve regurgitation

  30 day

• • Percentage of patients in whom the size of the ring is adjusted

  6 months

• • Technical feasibility of adjustment.

  The ability of the surgeon to adjust the Cardinal ring when required, will be measured on a scale of 1-3 (1- successfull, 3- unsuccessful)

  6 months

• • The occurrence of serious device related adverse events in all patients.

  6 months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are candidate for mitral valve repair, with our without concomitant procedures.

You may qualify if:

• Age \> 18 years
• Patient is a candidate for mitral valve repair, with our without concomitant procedures.
• Subject is willing to give informed consent for collection of his/her clinical data.

You may not qualify if:

• Severe organic lesions with retracted chordae
• Congenital malformations with lack of valvular tissue
• Severe valvular calcifications
• Evolving bacterial endocarditis
• Known Sensitivity to Nickel or Chromium

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (2)

SANA Herzchirurgie

Stuttgart, 70174, Germany

Location

Hospital San Rafaele

Milan, 20132, Italy

Location

Related Publications (1)

• Sundermann SH, Czesla M, Kempfert J, Walther T, Nataf P, Raanani E, Jacobs S, Alfieri O, Maisano F, Falk V. Results of mitral valve repair with an adjustable annuloplasty ring 2 years after implantation. Heart Vessels. 2017 Jul;32(7):843-849. doi: 10.1007/s00380-016-0934-7. Epub 2016 Dec 23.

  PMID: 28012074 BACKGROUND

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Ottavio Alfieri, Prof, MD

  Hospital San Raffaele, Milan, Italy

  PRINCIPAL INVESTIGATOR

• Nicolas Doll, Prof, MD

  SANA Herzchirurgie Stuttgart , Germany

  PRINCIPAL INVESTIGATOR

• Ehud Raanani, Prof, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Patrik Nataf, Prof, MD

  Bichat Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

• Volkmar Falk, Prof, MD

  Zurich University, Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 12, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IT (1)